A leading medical device company is seeking a highly motivated Clinical Project Manager (CPM) to lead clinical trials' planning, coordination, and oversight. This role will manage clinical operational plans, ensure they align with strategic objectives, and adhere to regulatory guidelines and Good Clinical Practice (GCP). The CPM will build strong global partnerships, oversee vendor relationships, and play a key role in driving the success of clinical projects that bring innovative medical solutions to market.
Principal Duties & Responsibilities:
Daily Project Coordination: Supervise and coordinate scheduled and ongoing clinical projects, ensuring timelines are met.
Primary Contact for Clinical Operations: Act as the main point of contact for all clinical study activities internally and externally.
Cross-functional Collaboration: Work with various teams to develop operational strategies, identify efficiencies, and ensure timely trial execution.
RFP and Vendor Management: Prepare Request for Proposal (RFP) materials, review vendor specs, and recommend selections.
Operational Planning & Compliance: Develop operational plans in compliance with regulatory guidance and GCP standards.
Study Timeline Development: Collaborate with stakeholders to create integrated study timelines.
Trial Operations Oversight: Manage vendor performance, key quality indicators, and communicate trial status to all stakeholders.
Documentation & File Management: Maintain accurate and up-to-date clinical trial files.
Vendor Performance Management: Oversee vendors to ensure adherence to Scope of Work (SOW), quality standards, and budget.
Clinical Trial Status Reporting: Regularly update Clinical Operations Management on trial progress and escalate critical issues as needed.
Clinical Document Contributions: Assist with the writing and review of protocols, informed consent, investigator brochures, and trial reports.
Trial Start-up to Closeout: Oversee all phases of clinical trials from start-up to closeout.
Vendor Invoice and SOW Management: Review and approve vendor invoices and manage changes to SOW.
Training & System Validation: Conduct site-level training and assist with system qualification and validation.
Travel Requirements: Travel up to 20% domestically for site visits and meetings.
Location:
Hybrid role with two days a week in the Bedford, MA office.
Education:
Bachelor's degree in life sciences or equivalent experience.
Experience:
5+ years in clinical trial management within a device or biopharma setting.
3+ years as a Project Manager.
2+ years managing vendors.
Knowledge & Skills:
Strong knowledge of FDA, GCP, and ICH guidelines.
Quality Assurance experience preferred.
Ability to thrive in a dynamic, fast-paced environment.
Working Conditions:
Extended computer use.
Up to 20% domestic travel for site visits and meetings.
This is an exciting opportunity for someone passionate about clinical operations, innovative medical technology, and a strong track record of successful project management. If you're looking to make a meaningful impact in the life sciences field, we'd love to hear from you!